Faculty of Pharmacy, Tehran University of Medical Sciences
Background- Nicorandil, a novel anti-anginal agent, has been characterized as having potent coronary vasodilator properties. It belongs to the group of potassium channel-opening vasodilators. Nicorandil possesses a dual mechanism of action: a nitrate-like effect, as well as potassium channel-opening properties.
This study was designed and performed to evaluate and compare the clinical efficacy and safety of nicorandil versus conventional anti-anginal therapy in Iranian patients with established multivessel coronary artery disease.
Patients and methods- A double-blind, randomized placebo-controlled clinical trial recruited and randomly assigned 50 patients with established multivessel coronary artery disease into two groups (N=25): the first group receiving 10mg nicorandil twice daily plus conventional anti-anginal therapy and the second group taking conventional anti-anginal therapy plus placebo. The total duration of the study for each patient was 12 weeks. A symptom - limited exercise test was performed to evaluate ischemic variables at baseline and then at two consecutive 6-week intervals. Major coronary events as well as adverse drug reactions were recorded initially and in the middle as well as the termination of the study to assess the safety and tolerability of nicorandil.
Results- Both groups had comparable baseline values for exercise tests. During treatment, time to the onset of ST-segment depression increased in both groups; however, the difference compared to baseline was only statistically significant in the ; nicorandil group. Exercise time was increased during treatment and follow-up period. Patients improvement in the nicorandil group was obviously much more considerable compared with that in the placebo - conventional therapy group. No patient experienced exacerbation of angina during nicorandil treatment. As for safety and tolerability, the distribution and frequency of adverse events were not significantly different between the groups.
Conclusion- Our data suggest that nicorandil improves exercise capacity and can be considered an effective and safe anti-anginal agent as an add-on to conventional therapy in patients with multivessel coronary artery disease.